Neurogen Biomarking Consent
The purpose of this consent form is to provide you with information about Neurogen Biomarking LLC and its affiliates, (collectively “Neurogen”, “we”, “us” or “our”) services and to obtain your informed consent for the use of the telehealth, biomarker counseling, and biomarker screening services (collectively the “Services”).
Telehealth Services. Telehealth services may involve the delivery of healthcare services to you by physicians, physician assistants, nurse practitioners, and/or other health professionals using the online platforms owned and operated by Neurogen.
Neurogen clinical partners provide services via telehealth. Telehealth involves the delivery of healthcare services using electronic communications, information technology or other means between a healthcare provider and a patient who are not in the same physical location. Telehealth may be used for diagnosis, treatment, follow-up and/or patient education, and may include, but is not limited to, one or more of the following: electronic transmission of medical records, photo images, personal health information or other data between a patient and a provider; interactions between a patient and provider via audio, video and/or data communications (such as messaging or email communications); use of output data from medical devices, sound and video files. Alternative methods of care may be available to you, such as in-person services, and you may choose an alternative at any time. Always discuss alternative options with your healthcare provider.
Biomarker Counseling Services. Biomarker counseling may also be available to you through Neurogen's clinical partners. Biomarker counseling services are provided by specially trained professionals who can help determine if biomarker screening is appropriate for you based on your personal medical history and family history, answer questions you have about biomarker screening, explain the result so any biomarker screening you have had and what they mean for you, and identify and help facilitate any medical follow up that may be needed following biomarker screening.
Benefits and Risks. Benefits of using Neurogen's services include making it easier for you to access healthcare services that may not be accessible through your healthcare provider or are not easily accessible. The potential risks associated with telehealth and biomarker counseling services include, but are not limited to, insufficient transmission of information that does not allow for appropriate decision-making and diagnosis by the health care provider; delays in diagnosis, consultation, and/or communication due to deficiencies or failures of equipment or systems; failure of security protocols, resulting in a breach of your privacy; or adverse results or reactions due to lack of access to complete medical records.
Biomarker Screening Services. Neurogen provides biomarker screening services to you. Screening will require the collection of a biospecimen using an FDA-cleared Tasso device using a collection kit provided to you by Neurogen. Your biospecimen will be shipped to a CLIA-certified, third-party laboratory selected by Neurogen. The laboratory will test for specific biomarkers in your blood sample.
Biomarker screening is highly accurate. A positive result may assist your healthcare provider to better predict the course of a condition and provide you with relevant treatment options, if they exist. However, some limitations apply to all biomarker screening that you should be aware of. Biomarker screening cannot identify all possible health conditions that you may develop in the future. Some health conditions may not be detected by the selected biomarker test. In addition, some technical limitations may prevent detection of some types of biological changes or may give inaccurate results due to poor biospecimen quality, rare technical errors in the laboratory, or other limitations. Finally, the interpretation of the biomarker test results included in the report is based on current medical knowledge, which may be evolving and incomplete. New discoveries, related to the relationship between certain biomarkers and diseases as well as the meaning of certain biomarkers are still being made. As such, it is possible that a biomarker variant causing a condition is not identified in the report as disease causing.
In some cases, additional testing to confirm the results may be recommended.
Biomarker screening is conducted by third-party laboratories, and neither Neurogen, nor your healthcare provider(s) can guarantee the accuracy or reliability of these tests. These laboratory tests can provide false negative, false positive, or inconclusive results that could impact your Provider(s) ability to correctly diagnose or treat you medical conditions. A failure or defect of these tests could also impact your healthcare provider's ability to correctly diagnose or treat your medical conditions.
Results for any test ordered by your healthcare provider will be maintained electronically by Neurogen or its third-party vendors. Neurogen will make results available electronically to you and any healthcare provider you ask Neurogen to share the results with. Results may also be made available to individuals/organizations with a legal right of access under applicable Federal and/or State law, or as authorized by the patient or the patient's representative.
Consent to Data Processing
To Provide the Services. Neurogen provides individualized services based on analysis of the biospecimen you provide, the information derived therefrom, and other Personal Information provided by or about you through your use of the Services. As such, we must obtain your consent prior to processing this information. Neurogen will process your Personal Information for as long as we provide you with our Services or as permitted or required by law.
Our collection, use and disclosure of your Personal Information are governed by our Privacy Policy and we encourage you to read it prior to giving consent.
As described in our Privacy Statement, we may use your sensitive information for the following purposes:
- Provide our Services, including operating, improving, maintaining, and protecting those Services, as well as developing new Services
- Analyze trends and usage of the Services
- Communicate with you and to share information we think may be relevant to you including information about existing and new products and services
- Personalize, contextualize and market our Services to you
- Prevent fraud or other unauthorized use of our Services
- Investigate conduct that violates our Terms of Service
- Conduct surveys or polls
- Comply with our legal or other statutory or regulatory obligations
- Conduct research in accordance with additional consents you provide, as required under applicable law.
If you do not consent to the collection and processing of your Personal Information provided by or about you through your use of the Services, you will not be able to use our Services. If you would like more information about how we collect, use and process your Personal Information, including your privacy rights, please review our full Privacy Policy.
Who do I contact if I have questions?
For general questions or help with Neurogen’s Services, contact: